Phase 1/Phase 2 Trial to Treat Dyskinesias in Parkinson’s Disease

Neuraltus Pharmaceuticals has initiated a Phase 1/Phase 2 clinical study of their compound NP002 to treat dyskinesias due to levodopa therapy in subjects with idiopathic Parkinson’s disease.

Levodopa is the mainstay of Parkinson’s disease treatment regimens; however, levodopa is associated with drug-induced disabling dyskinesias, jerky movements that are often as severe as the symptoms of Parkinson’s disease. The goal of this clinical trial is to demonstrate that NP002 is generally safe and well tolerated and can reduce these dyskinesias to allow Parkinson’s patients to receive the benefits of the levodopa therapy without suffering from debilitating dyskinesias.

There is no approved treatment for levodopa-induced dyskinesias and this represents a major unmet medical need. Recently, NP002 was shown to effectively treat the levodopa-induced dyskinesias in the MPTP-monkey model of Parkinson’s disease, the gold-standard animal model of Parkinson’s disease.

The trial is a randomized, double-blind, parallel group, placebo-controlled, safety, tolerability and dose-finding study with a target enrollment of approximately 60 subjects at up to 10 sites. The estimated date for final completion of the study is May, 2011.

Neuraltus is currently recruiting patients for this study. To be included in the study, subjects must meet a number of criteria. These criteria include: a clinical diagnosis of idiopathic Parkinson’s disease, a stable dose of levodopa for at least 3 months, and moderately or severely disabling dyskinesias. Subjects will be excluded from the study for a number of reasons, including the following: if they have parkinsonian symptoms that do not respond to levodopa therapy, or if they are smokers or have smoked in the previous five years or have regular exposure to secondhand smoke. For more information on the clinical study, see the description of the study on the National Institutes of Health website, www.clinicaltrials.gov or e-mail Neuraltus at clintrials@neuraltus.com.